The Opportunity
Our client is seeking an experienced Senior Manager, Sterility Assurance to play a critical role in protecting the sterility and quality of products manufactured at their site.
This is a senior technical role with responsibility for developing and driving the site's Sterility Assurance strategy, with a particular focus on contamination control, aseptic manufacturing, microbiological risk management and regulatory compliance.
Working closely with Quality, Manufacturing, Engineering and Microbiology teams, you will provide subject matter expertise across the sterile manufacturing operation and play a key role in maintaining a robust Contamination Control Strategy (CCS) and ensuring continued compliance with EU GMP Annex 1 and other global regulatory requirements.
Key Responsibilities
- Lead the site-wide Sterility Assurance strategy and programme, ensuring alignment with EU GMP Annex 1 and applicable global regulatory expectations.
- Develop, maintain and continuously improve the site Contamination Control Strategy (CCS) for sterile manufacturing operations.
- Provide technical leadership on contamination control across aseptic processes, facilities, personnel, utilities, environmental monitoring and container closure systems.
- Lead and contribute to microbiological and sterility-related risk assessments, identifying potential contamination risks and implementing appropriate controls.
- Oversee and continuously improve the Environmental Monitoring (EM) programme, including trending, data interpretation and identification of emerging risks.
- Lead and support microbiological investigations, deviations and sterility assurance-related events, ensuring robust root cause analysis and effective CAPA implementation.
- Coordinate and oversee Aseptic Process Simulations, including protocol development, execution oversight, investigation and review of associated documentation.
- Provide sterility assurance expertise into validation and qualification activities, including aseptic process validation, sterility testing and relevant laboratory systems.
- Support the site during internal and external audits and regulatory inspections, acting as a sterility assurance subject matter expert and supporting responses to observations.
- Partner closely with Quality, Manufacturing, Engineering and Microbiology to ensure consistent application of sterility assurance and contamination control principles.
- Review, approve and maintain key technical documentation, including SOPs, validation protocols, risk assessments, CCS documentation and contamination control plans.
- Monitor sterility assurance performance indicators, trends and emerging risks, using data to identify opportunities for continuous improvement.
- Provide technical guidance and mentorship to colleagues and contribute to the development of a strong quality and contamination control culture across the site.
About You
Our client is looking for an experienced sterility assurance professional with a strong microbiology foundation and extensive experience within a sterile or aseptic manufacturing environment.
You will ideally bring:
- A Bachelor's degree or higher in Microbiology, Biotechnology or a closely related scientific discipline.
- Significant experience in Sterility Assurance, Aseptic Manufacturing, Pharmaceutical Microbiology or a closely related discipline.
- Strong practical knowledge and application of contamination control strategies within sterile manufacturing.
- Hands-on experience with aseptic processing, environmental monitoring and microbiological contamination control.
- Knowledge and practical experience of cleaning and disinfection programmes and validation, including disinfectant efficacy considerations.
- Strong understanding of EU GMP Annex 1, together with relevant US FDA, EMA and wider global GMP requirements relating to sterile manufacture and contamination control.
- Experience supporting or leading regulatory inspections and GMP audits within sterile manufacturing environments.
- A proven track record in deviation management, microbiological investigations, root cause analysis, CAPA and risk assessment.
- Experience developing, implementing or maintaining a Contamination Control Strategy (CCS).
- Strong understanding of environmental monitoring programmes, microbiological trending and data interpretation.
- The ability to work effectively across Quality, Manufacturing, Engineering and laboratory functions, providing credible technical challenge and guidance.
- Strong communication skills, with the ability to explain complex microbiological and sterility assurance concepts to both technical and non-technical stakeholders.
What Makes This Role Different?
This is a senior technical specialist position, rather than a traditional people-management role. You will have significant influence across the site and will be relied upon as a subject matter expert in sterility assurance, contamination control and aseptic manufacturing.
The successful candidate will bring a strong microbiology background combined with extensive practical sterility assurance experience and will be comfortable taking ownership of complex technical issues, leading investigations and influencing cross-functional teams.
Working Arrangements
- Location: Fully onsite
- People Management: No direct line management responsibility
- Level: Senior technical/subject matter expert
- Environment: Sterile / aseptic pharmaceutical manufacturing
If you are an experienced microbiologist or sterility assurance professional looking for an opportunity to take ownership of site-wide contamination control and sterility assurance strategy, we would be keen to hear from you.
